FDA Advances Toward Covid-19 Vaccine Authorization

Due to limited supplies, the first doses are expected to go to health workers treating Covid-19 patients and nursing-home residents.

More shots will become available to more Americans, starting with people such as essential workers, as vaccine production increases. Yet most Americans won’t get vaccinated until spring or summer, according to health authorities.

Supplies won’t be sufficient to make a serious difference in the coronavirus pandemic this winter, said BioNTech Chief Executive Ugur Sahin. BioNTech and Pfizer are scaling up production with the aim of being able to produce up to 100 million doses by January at the latest, he said.

“Ideally, we should be able to produce even more than that,” Dr. Sahin said in an interview.

FDA Commissioner Stephen Hahn and Peter Marks, director of the FDA’s center for biologics, said they had told the drugmakers and the government’s Operation Warp Speed of the agency’s efforts.

The agency “will rapidly work toward finalization and issuance of an emergency use authorization,” the officials said.

They issued their statement after President Donald Trump criticized the pace of the agency’s review on Twitter, saying the FDA was “a big, old, slow turtle” and urging Dr. Hahn to clear the vaccine immediately.

“Stop playing games and start saving lives!!!” Mr. Trump tweeted.

Vaccines normally take years to develop and months to review. The launch of the Pfizer-BioNTech vaccine would happen in less than a year, a record time.

Given the urgent need, the FDA conducted a faster review of the shot than it normally does. The result will be the agency issuing an authorization for emergency use, rather than the typical approval.

The FDA has issued several emergency-use authorizations for drugs during the pandemic. Its emergency-use authorization of the Pfizer-BioNTech vaccine is expected to become final Friday or over the weekend.

The Pfizer-BioNTech vaccine was 95% effective and generally well-tolerated in a 44,000-person late-stage trial. On Thursday, a panel of independent medical advisers recommended that the FDA clear the inoculation for wide use.

In the U.S., the first recipients are slated to be hospital and first-line medical workers, as well as residents of nursing homes. Federal officials have said the distribution is expected to commence within 24 hours of a final FDA decision.

The Pfizer-BioNTech vaccine has already been cleared by regulators in the U.K. and Canada. After two health workers in the U.K. developed allergic reactions, the country’s health authorities warned that people who have a history of serious allergic reactions shouldn’t get inoculated.

Write to Thomas M. Burton at [email protected] and Bojan Pancevski at [email protected]